Filed
Pursuant to Rule 424(b)(3)
Registration
No. 333-143755
Prospectus
Supplement No. 1
(to
Prospectus dated December 10, 2007)
CLEVELAND
BIOLABS, INC.
5,514,999
Shares
This
Prospectus Supplement No. 1 supplements and amends the prospectus dated December
10, 2007 (the “Prospectus”) relating to the offer and sale of up to 5,514,999
shares of our common stock which may be offered from time to time by the
selling
stockholders identified in the Prospectus for their own accounts. This
Prospectus Supplement is not complete without, and may not be delivered or
used
except in connection with the original Prospectus.
This
Prospectus Supplement No. 1 includes the attached Form 8-K of Cleveland BioLabs,
Inc. dated January 4, 2008, as filed by us with the Securities and Exchange
Commission.
This
Prospectus Supplement No. 1 modifies and supersedes, in part, the information
in
the Prospectus. Any information that is modified or superseded in the Prospectus
shall not be deemed to constitute a part of the Prospectus, except as modified
or superseded by this Prospectus Supplement No. 1. We may amend or supplement
the Prospectus from time to time by filing amendments or supplements as
required. You should read the entire Prospectus and any amendments or
supplements carefully before you make an investment decision.
Investing
in our common stock involves risk. See “Risk Factors” beginning on page 8 of the
Prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved of these securities or determined if the Prospectus
or
this Prospectus Supplement No. 1 is truthful or complete. Any representation
to
the contrary is a criminal offense.
The
date
of this Prospectus Supplement No. 1 is January 4, 2008.
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of
Report: (Date of earliest event reported): January 4, 2008
CLEVELAND
BIOLABS, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-12465
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20-0077155
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(State
or other jurisdiction
of
incorporation or organization)
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(Commission
File Number)
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(I.R.S.
Employer
Identification
Number)
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73
High Street, Buffalo, New York 14203
(Address
of principal executive offices)
Registrant’s
telephone number, including area code: (716) 849-6810
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
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¨
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Written
communications pursuant to Rule 425 under the Securities Act
(17 CFR
230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17
CFR
240.14a-12)
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¨
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR
240.14d-2(b))
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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange
Act (17 CFR
240.13e-4(c))
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Item 8.01
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Other
Events
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On
January 4, 2008, the Company issued a press release announcing that it
was notified by the U.S. Department of Defense that it was not selected
for a
contract award granted in connection with a U.S. Department of Defense
request
for proposal relating to medical radiation countermeasures. A copy of
the press
release is attached as Exhibit 99.1.
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Item 9.01
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Financial
Statements and Exhibits
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(d) Exhibits
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Exhibit
No.
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Exhibit
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99.1
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Press
Release dated January 4, 2008.
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SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned
hereunto
duly authorized.
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CLEVELAND
BIOLABS, INC.
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Date:
January 4, 2008
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By: |
/s/
Michael Fonstein
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Michael
Fonstein
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President
and Chief Executive
Officer
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EXHIBIT
INDEX
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Exhibit
No.
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Exhibit
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99.1
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Press
Release dated January 4, 2008.
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 |
FOR
IMMEDIATE RELEASE
Cleveland
BioLabs Not Selected for Defense Contract Award
Company
to Host Conference Call to Discuss Ongoing Development Strategy for Pipeline
of
Compounds
Buffalo,
NY — January 4, 2008 - Cleveland BioLabs, Inc. (NASDAQ:CBLI)
today
announced that it was informed by the Department of Defense (DoD) that
Protectan
CBLB502, the Company’s candidate for the treatment of gastrointestinal (GI)
effects of acute radiation syndrome was not selected for award under the
request
for proposal (RFP) No. W9113M-07-R-0002, entitled, “Medical Radiation
Countermeasures Development and Delivery.”
The
Company is very surprised by the DoD’s decision and has requested a debriefing
in order to better understand the DoD’s decision. In June 2007, based on the
DoD’s evaluation of the Company's technical and cost proposal, the DoD informed
the Company that its proposal for Protectan CBLB502 was within the competitive
range and invited Cleveland BioLabs for a face-to-face meeting on July
26, at
which the details of the Company’s proposal were discussed. The DoD reaffirmed
this positive feedback in September 2007, when it requested an additional
amendment asking for an increased development budget, as well as up to
1.5
million doses of a self or buddy-administered countermeasure for use in
the
battlefield.
Dr.
Michael Fonstein, Chief Executive Officer and President of Cleveland BioLabs
stated, “Given the aggressive nature and degree of detail of the DoD’s responses
and ensuing negotiations regarding our proposal, we are deeply disappointed
by
this unexpected decision. We intend to further develop CBLB502 and seek
FDA
approval and will respond to future DoD solicitations as they are announced.
Cleveland BioLabs’ research has demonstrated CBLB502’s unique ability to
mitigate the damaging effects of ionizing radiation on all major acute
radiation
syndromes, including gastrointestinal, as well as to demonstrate significant
survival benefits. In addition, the compound’s safety profile, stability and
method of administration make it highly practical for field deployment,
both for
military and civilian populations.”
Cleveland
BioLabs Chief Scientific Officer, Andrei Gudkov, Ph.D, D. Sci., said, “We
believe our Protectan CBLB502 is quite unique in three particular areas
with
strong supporting data: The first is prolonged survival or long-term survival
benefits, which we have demonstrated in both mice and primates; the key
FDA
requirements for drug approval under the two-animal efficacy rule. The
second is
protection of the GI tract, which we have demonstrated in two animal species.
The third is its remarkable stability, a significant shelf life and its
suitability for easy self and buddy-administration in battlefield, civilian
or
hospital conditions. Moreover, the technology we developed for CBLB502
allowed
cost-effective production of over 100,000 doses per manufacturing batch
under
cGMP conditions, which could provide protection for the numbers of military
forces potentially exposed to radiation from tactical nuclear weapons in
the
field or terrorist attacks directed against civilian populations.”
“We
remain committed to developing Protectan CBLB502 for both defense and medical
uses,” added Dr. Gudkov. “We plan to continue our discussions with the
Department of Health and Human Services and other friendly governments,
who are
interested in its potential to protect against terrorist threats and nuclear
disaster. Our
goal
is to achieve FDA approval for CBLB502 in 2009 and market it as an effective
and
affordable radiation protector for defense use on the battlefield or in
first
responder or civilian emergencies.”
Protectan
CBLB502 is undergoing an accelerated development program under the FDA
two-animal rule for defense, which requires demonstrations of efficacy
in two
animal species and only safety in humans. As planned, the Company will
submit an
Investigational New Drug application to the FDA for a human safety study
shortly.
The
Defense Threat Reduction Agency of the DoD awarded Cleveland BioLabs a
grant in
March 2007, to fund ‘development leading to the acquisition’ of Protectan
CBLB502 as a radiation countermeasure, in collaboration with the Armed
Forces
Radiobiology Research Institute, which has also received significant independent
funding for work on Protectan CBLB502. The DoD also recently awarded a
$1
million grant to the Company’s founding partner, the Cleveland Clinic, to
conduct pre-clinical studies on Protectan CBLB502 for use in tourniquet
and
other ligation-reperfusion battlefield injuries where blood flow is stopped
and
then restored after a prolonged period of time.
Potential
medical applications for CBLB502 are broad and include reduction of radiation
therapy side effects in cancer patients, and ischemic diseases such as
acute
organ failure, heart disease and stroke. Protectan CBLB502 has shown efficacy
as
a potential adjuvant for radiation therapy in mouse models of sarcoma and
Company researchers in collaboration with investigators from Cleveland
Clinic
have demonstrated that a single injection of Protectan CBLB502 effectively
prevents acute renal failure and subsequent death in a mouse model of
ischemia-reperfusion renal injury.
Cleveland
BioLabs’ scientific platform has yielded several other compounds in addition to
Protectan CBLB502. These include other tissue protecting drugs, Protectans,
as
well as anticancer compounds, Curaxins. Among the more advanced of these
compounds is Curaxin CBLC102, an orally administered small molecule designed
to
kill tumor cells in Phase II trials, and Protectan CBLB612, which has
demonstrated strong potential efficacy as a stimulator and mobilizer of
hematopoietic stem cells in peripheral blood.
The
Company will host a conference call to discuss the DoD decision and its
ongoing
development strategy today at 8:30 a.m. Eastern Standard Time. Interested
parties may participate by dialing 877-407-8033 (US) or 201-689-8033
(International) approximately five to ten minutes before the call start
time. A
live Webcast of the conference call will be available on
the
Cleveland BioLabs Web site at www.cbiolabs.com.
A
replay
of the call will be available starting on January 4, 2008, at 12:00 p.m.
Eastern
Standard Time through January 11, 2008 at 11:59 p.m. Eastern Standard Time.
Interested parties may access the replay by dialing 877-660-6853 (US) or
201-612-7415 (International) and entering account number 286 and conference
ID
number 268331. An archived Webcast of the conference call will be available
on
the Cleveland BioLabs Web site at www.cbiolabs.com.
About
Cleveland BioLabs, Inc.
Cleveland
BioLabs, Inc. is a drug discovery and development company leveraging its
proprietary discoveries about programmed cell death to treat cancer and
protect
normal tissues from exposure to radiation and other stresses. The Company
has
strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute,
ChemBridge Corporation and the Armed Forces Radiobiology Research Institute.
To
learn more about Cleveland BioLabs Inc., please visit the company's website
at http://www.cbiolabs.com.
This
press release contains forward-looking statements within the meaning of
the
Private Securities Litigation Reform Act of 1995. Forward-looking statements
reflect management’s current expectations, as of the date of this press release,
and involve certain risks and uncertainties. Our actual results could differ
materially from those anticipated in these forward-looking statements as
a
result of various factors. Some of the factors that could cause future
results
to materially differ from the recent results or those projected in
forward-looking statements include the "Risk Factors" described in our
filings
with the Securities and Exchange Commission.
Contacts:
Rachel
Levine, Director Corporate Development & Communications
Cleveland
BioLabs, Inc.
T:
(646)
284-9439
E:
rlevine@cbiolabs.com